News & Analysis as of

Department of Health and Human Services (HHS) Hospitals

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 8, July 2025

Welcome to our eighth issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the rural health "slush fund" included in the Federal budget bill, the effect of Medicaid...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

Venable LLP on

On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Epstein Becker & Green

Latest Moves by Federal Agencies Regarding Gender-Affirming Care: Risks Mount for Providers

Epstein Becker & Green on

Since day one, a policy priority of the Administration has been to discourage and prevent gender-affirming care for children and adolescents that involves surgery or medication....more

Epstein Becker & Green

CMS’s Rescission of 2022 EMTALA Guidance Presents New Considerations for Hospitals, Post-Dobbs

Epstein Becker & Green on

The Centers for Medicare & Medicaid Services (CMS) recently rescinded its July 2022 guidance titled “Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss” (“2022...more

Holland & Knight LLP

Office of Inspector General Highlights Flat Fee Structures Not Immune From Anti-Kickback Statute

Holland & Knight LLP on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-08 (Opinion) on July 7, 2025, highlighting the limitations of the often-leveraged Personal Services and...more

Rivkin Radler LLP

OCR Announces $800,000 HIPAA Settlement with Florida Health System

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced another settlement for alleged violations of HIPAA. OCR investigated BayCare Health System, which serves central Florida, after a...more

Harris Beach Murtha PLLC

Scrutiny of Hospital–Physician Relationships Continues

Despite changes in many priorities, the federal government’s scrutiny of relationships between hospitals and physicians continues well into 2025. Last month, Community Health System (CHS) in California and its affiliate,...more

King & Spalding

OIG Audit of Provider Relief Fund Payments to Hospitals Finds Substantial Noncompliance with Federal Requirements

King & Spalding on

On June 13, 2025, OIG announced the results of an audit it conducted of 30 hospitals that received provider relief fund (PRF) payments during COVID-19 (the Audit). OIG found that 11 of the 30 audited hospitals failed to...more

Epstein Becker & Green

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

Foley Hoag LLP on

I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Dinsmore & Shohl LLP

D.C. District Court Declines Manufacturers’ Unilateral Efforts to Move Forward with Proposed 340B Rebate Models

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Last month, the United States District Court for the District of Columbia (the “District Court”) evaluated Motions for Summary Judgment concerning drug manufacturers’ efforts to unilaterally pay 340B Program discounts in the...more

Morgan Lewis - As Prescribed

340B Under the Microscope: Key Trends and Takeaways for 2025

The 340B Drug Pricing Program (the Program) has long been a cornerstone for healthcare providers seeking to deliver affordable care to underserved communities. However, as the regulatory and compliance landscape evolves,...more

Katten Muchin Rosenman LLP

HHS Rescinds 2022 EMTALA Guidance on State Law Preemption in Emergency Reproductive Healthcare

On May 29, 2025, the Department of Health and Human Services (“HHS”) rescinded its July 11, 2022 guidance (Ref. QSO-22-22-Hospitals) (the “2022 Guidance”) clarifying how the Emergency Medical Treatment and Labor Act of 1965...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #4

News Briefs - Judge Rules Against Administration's HHS Reorg, Reductions - California District Judge Susan Illston has granted a preliminary injunction against the Trump administration's recent reductions in force across...more

King & Spalding

Budget Reconciliation Bill Impacts Medicaid Financing, Programs, and Eligibility

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Last week, the House Energy & Commerce Committee marked up legislation that would significantly affect the Medicaid program, including changes to state Medicaid financing mechanisms, state directed payment programs that...more

McDermott+

CMS Requests Hospitals Submit Gender-Affirming Care Data- (UPDATED)

McDermott+ on

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

McDermott Will & Schulte

CMS Requests Hospitals Submit Gender-Affirming Care Data

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

McDermott+ on

Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...more

Lathrop GPM

Administration Issues Cross-Agency Guidance Targeting Health Care Pricing and Focusing on Hospitals and Health Plans

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On May 22, 2025, the U.S. Department of Health and Human Services, Department of Treasury and Department of Labor (the “Agencies”) announced new steps intended to “strengthen healthcare price transparency.” ...more

Proskauer - Health Care Law Brief

Disproportionate Impact: Supreme Court Narrows Disproportionate Share Hospital Reimbursement to Supplemental Security Income Cash...

The U.S. Supreme Court has issued a significant ruling affecting hospitals that serve low-income Medicare beneficiaries, narrowing the interpretation of the Disproportionate Share Hospital (“DSH”) payment formula. In...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #2

News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more

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